Bioequivalence and Bioavailability Forum

Dear Vivekanand,

first of all please read – and follow – this post. Are you on the run? Why are you forcing us to read your posts full of typographical errors?

I would suggest that you do your homework first. Talk to colleagues and rely on your own judgment before trying to drown forum’s members in posts of interrelated content. See also the sentence in my signature below. Select an appropriate category for your post. If you really believe that everything is regulated (since you always posted in Regulatives / Guidelines]) I’m afraid you are on the wrong track.

Concerning your questions:
Such a change is irrelevant. Why do you think that the IEC or regulators will have concerns if person B instead of person A evaluates the study with the same methods specified in the protocol?

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  Enlightenment is man’s emergence from his self-imposed nonage for which he himself was responsible. Nonage is the inability to use one’s own intellect without the direction of another. This nonage is self-imposed if its cause lies not in lack of intelligence, but in a lack of determination and courage to think without the direction of another. Sapere aude! Have courage to use your own understanding! is therefore the slogan of Enlightenment.
   Immanuel Kant, Answering the Question: What is Enlightenment? (1784)